About
Founded in 2024, our small team of SFDA experts excels in medical device registration procedures. With years of experience, we guide you through the complexities of the Saudi regulatory procedures seamlessly.
Our dedication to excellence and client-oriented approach sets us apart. Trust us to navigate the ever-changing landscape of Saudi FDA regulations with precision and expertise.
Services
Authorized Representative License (AR)
Applying for an ARL is mandatory for a manufacturer to export his products to Saudi Arabia, and it is impossible for the Saudi Dealer/Distributor to import products without being the authorized representative. It is the foundation of any product registration to come.
Medical Device Registration (MDMA)
Regulatory Bridge specializes in assisting medical device manufacturers, dealers, and distributors with Saudi FDA - Medical Device Marketing Authorization in Saudi Arabia. Our team of experts guides clients through the regulatory process, specifically the technical file assessment - TFA Route, ensuring compliance with all necessary requirements and streamlining the registration process for a smooth and efficient experience. With Regulatory Bridge, you can trust that your medical devices will meet all necessary standards for distribution in the Saudi Arabian market.
Cosmetic Product Notification
Ensuring accurate documentation and thorough product information for your cosmetic goods is essential to facilitate smooth customs clearance and obtain the Certificate of Conformity (COC) from Saudi approved regulatory bodies.
Product Classification (PCS)
Should you find yourself in a situation where you are uncertain whether your product falls under Medical Devices, Drugs, or Cosmetics, we offer the option to have the SFDA classify your product. Nevertheless, in the majority of cases, we are prepared to assist you in accurately classifying your product at no additional cost.
Documentation
Get expert assistance in efficiently organizing and preparing all required SFDA documentation, forms, and justifications tailored to your specific request type.
Transfer Products from Old AR
When distributing/dealing in products formerly sold by a dealer or distributor, you can avoid the hassle of reapplying or reregistering them. Instead, consider opting for an Authorized Representative License Transfer. This process seamlessly integrates the previously registered products into your account. You also have the option to renew any expired products easily and at a reduced cost. Take advantage of this convenient solution for managing products from former dealers with ease.
Why work with us
We provide expert guidance to navigate the complex SFDA regulatory landscape, ensuring compliance and peace of mind for your business.
Our tailored solutions are customized to meet your specific needs, saving you time and resources while streamlining the regulatory process.
Count on our timely support to address any regulatory challenges promptly, minimizing disruptions and keeping your operations running smoothly.
Our Team
At Regulatory Bridge, our team of doctors and pharmacists possess in-depth knowledge on medical products and are well-versed in Saudi FDA document requirements. Our original academic medical background strengthens our experience as it is essential for your regulatory specialist to understand the product prior to attempting to register it. With over 6 years of experience in regulatory services, we are committed to providing expert consultation and support to ensure the successful navigation of regulatory processes for our clients.
Contact
We are here to help with any questions or inquiries you may have. Reach out to us now!
